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The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.

The Invisio IRL Digital Rigid Laparoscope is a standard USA Series Laparoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image replacing the rod lens system typically used in the rigid laparoscope The Invisio IRL Digital Rigid Laparoscope can be inserted into the abdomen or chest through small skin cuts allowing the surgeon to explore the whole cavity without the need of making large standard openings dividing skin and muscle.

I am sorry, but without a clear description of acceptance criteria or a study within the provided text, I cannot complete your request. The provided text primarily describes a device for a 510(k) submission, including its name, predicate devices, and intended use. It does not contain information on acceptance criteria, device performance results, study methodologies (like sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or training/test set details.

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